ACTRN12616000194460招募中未知
A pre and post study of the effect and safety of Hominax to improve sperm health
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 62
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 20 Years 至 60 Years（—）
- 性别
- Male
入选标准
- •1.Age 20 to 60 years;
- •2.Evidence of a personally signed informed consent document indicating that the subject has been informed of all pertinent aspects of the study;
- •3.Normal rheologic characteristics (appearance, consistency, and liquefaction) of semen, and pH in the normal range;
- •4.Sperm concentration between => 5 x 106/mL and at least ONE of the following within 3 months prior to screening visit:
- •a.Sperm concentration <= 15 x 106/mL [1, 2] OR
- •b.Progressive motility (PR, %) [1, 2] ) <= 32% OR
- •c.Normal sperm morphology <= 4% [1, 2] on two semen samples 7-21 days apart within 3 months of enrollment into the study;
- •5.Seminal white blood cells <1 x 106/mL;
- •6.Willing to cease all vitamin and complementary medicine supplements from screening and for the duration of participation in the study;
- •7.Fluent in spoken & written English;
- •8.Patients must be accessible for treatment and follow-up; Able to swallow capsules whole;
- •9.Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
排除标准
- •1.Non-idiopathic infertility. That is, participants to be excluded if their infertility has a known cause such as, but not limited to: infectious genital diseases, anatomic abnormalities of the genital tract including clinical varicocele, anti-spermatozoa antibodies, taking medication with known spermicidal effects;
- •2.Leucocytospermia (WBC >1 x106 ml in seminal plasma);
- •3.Sperm concentration < 5 x 106/mL in the semen sample used to confirm male factor infertility to exclude severe condition;
- •4.Smoking if greater than or equal to 1 pack per week (on average),
- •a.Alcohol if greater than or equal to 20 grams alcohol (equivalent to 2 standard drinks, on average, per day) or
- •b.Drug addiction to any substance, and occupational chemical exposure;
- •5.If diagnosed with a bleeding disorder; or hypothyroidism; or seizures; or HIV/AIDs; or hepatitis of any cause; or an autoimmune disease; or planning to have angioplasty during the study;
- •6.If taking thyroid hormone, or anti-coagulant or anti-platelet medication, or anti-seizure medication, or HIV/AIDs medication; or barbiturates;
- •7.Has known allergies or hypersensitivities to the components of Hominax or capsule excipients.
- •8.Has a history of gastrointestinal condition and/or experiences adverse reactions to swallowing medications (e.g. vomiting, reflux etc.) and / or during digestion of medications after consumption (e.g. acute diarrhoea/constipation; abdominal cramps; occult blood etc.)
- •9.Has significant cardiovascular, renal, hepatic, pulmonary, endocrine, metabolic or haematological disorders;
- •10.Diabetes Mellitus requiring insulin therapy;
- •11.Has current psychiatric illness or dementia (excluding clinically diagnosed depression or anxiety where the patient has been stable on medication for at least three months);
- •12.Any serious medical or psychological disorders likely to preclude completion of the study.
研究者
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